Nutrition and Lung Function for Cystic Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how nutrition and body composition affect individuals with Cystic Fibrosis (CF), particularly concerning lung function. Researchers will use various tests to compare participants' muscle and body strength to a standard method called DXA, which measures bone and body composition. The goal is to better understand these factors and their potential impact on overall health and treatment outcomes in CF. Individuals with CF who have experienced lung function issues, as measured by a common breathing test, may be suitable for this study. As an unphased trial, this study allows participants to contribute to foundational research that could enhance future CF treatments.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you cannot start any new chronic therapies or investigational drugs within 28 days before the study begins. If you are on antibiotics or corticosteroids for respiratory symptoms, you must stop them at least 14 days before the study starts.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the tests and tools used in this trial, including the 1-minute sit-to-stand test, 6-minute walk test, hand-grip strength measurement, and DXA scan (which assesses bone and muscle health), are generally safe and well-tolerated.
For example, the sit-to-stand test can enhance muscle quality without causing serious side effects. The 6-minute walk test tracks physical function and correlates with lean body mass, with no major safety concerns reported. Hand-grip strength is a common and safe test for muscle health, even in older adults.
DXA scans are widely used in clinics to measure body composition and are considered low-risk, involving minimal radiation similar to an X-ray.
Lastly, spirometry, which measures lung function, is safe but can cause dizziness in some individuals due to deep breathing. Overall, these tools are commonly used in healthcare and have a strong safety record.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores new ways to measure and improve physical function and lung health in individuals with cystic fibrosis (CF). Unlike traditional treatments focused solely on medications to improve lung function, this trial uses advanced techniques like Dual X-Ray Absorptiometry (DXA) to assess muscle mass and strength, alongside common metrics like spirometry. The trial aims to find links between muscle health and lung function, potentially leading to more holistic approaches to managing CF by improving overall physical performance and quality of life.
What evidence suggests that this trial's treatments could be effective for cystic fibrosis?
Research has shown that several tests effectively assess muscle strength and body composition in people with cystic fibrosis (CF). In this trial, participants in different cohorts will undergo various assessments. The 1-minute sit-to-stand test, part of the assessments, relates to lean mass, demonstrating the connection between muscle strength and body composition. The 6-minute walk test measures how far someone can walk in six minutes and often assesses exercise capacity and endurance. Hand-grip strength serves as a key indicator of overall muscle function and physical ability. Dual X-ray absorptiometry (DXA) provides a precise analysis of body composition, including muscle and fat mass. Lastly, the Short Physical Performance Battery (SPPB) effectively evaluates muscle strength and physical performance. Together, these tools offer a clear picture of muscle and body health in CF patients.14678
Who Is on the Research Team?
Adam Stein
Principal Investigator
Northwestern University
Melissa Putman
Principal Investigator
Massachusetts General Hospital
Jessica Alvarez
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments including DXA scans and other body composition measurements
Longitudinal Assessment
Participants are monitored for changes in body composition and other health metrics over time
Follow-up
Participants are monitored for safety and effectiveness after the main assessment period
What Are the Treatments Tested in This Trial?
Interventions
- 1-minute site to stand
- 1 minute site to stand and lean mass index from DXA
- 6-minute walk
- 6 minute walk and lean mass index from DXA
- Accelerometry to assess physical activity
- BIA Substudy
- BIA Sub-study
- BMI and lean mass index from DXA
- Chest CT scans
- Chest CT scans (When available within the past 6 months) to assess
- Continuous glucose monitoring (CGM)
- Food logging
- Gastrointestinal (GI) and nutrition questionnaires
- Hand-grip strength
- Hand-grip strength and lean mass index from DXA
- Hologic Dual X-Ray Absorptiometry (DXA)
- Hunger Vital Sign
- Oral glucose tolerance testing (OGTT)
- Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
- Psychosocial questionnaire: CF Fatalism Scale
- Psychosocial questionnaire: GAD-7
- Psychosocial questionnaire: PHQ-8
- Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
- Respiratory symptom questionnaire: CRISS
- Short physical performance battery (SPPB)
- Short physical performance battery (SPPB) frailty score and lean mass index from DXA
- skinfold and circumference
- Spirometry
- STRONG Participant Experience Survey
- Sub-study of assessment of appendage muscles using ultrasound
- Tricepts skinfold (TSF) and Mid-arm muscle circumference (MAMC) and lean mass index from DXA
- Ultrasound Sub-study of assessment of appendage muscles using ultrasound
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Forced expiratory volume in 1 second (FEV1) \<70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation). If no stable spirometry data are available in the 12 months prior to enrollment, from the prior 24 months will be used.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jaeb Center for Health Research
Lead Sponsor
Citations
Strength and Muscle Related Outcomes for Nutrition and ...
Correlation between DXA lean mass index and the 1-minute sit-to-stand number of repetitions, Estimate and compare correlation between lean mass index from DXA ...
Body Composition by DXA - PMC
We will discuss lean mass indices, including appendicular lean mass index (ALMI = [arms + legs lean mass] / Height2) in the next section.
Relationship between skeletal muscle indicators and ...
Clinical outcomes included physical functionality [hand grip strength (HG), one ... one-minute sit-to-stand test (STST).(24) Participants stood ...
Lean tissue mass measurements by dual-energy X-ray ...
Dual energy X-ray absorptiometry (DEXA) is a widely available, cost-effective and sensitive technique for measuring whole body and regional lean tissue mass.
Skeletal Muscle Mass Recovery Early After Left Ventricular ...
There were significant gains in skeletal muscle mass, as represented by dual X-ray absorptiometry fat free mass and ALM, over the first 6 months of LVAD ...
Are we giving too much weight to lean mass loss?
Illustrative of this, obese patients with the highest body mass index (BMI) and markers of insulin resistance have a ∼2-fold and ∼3.5-fold increased risk of all ...
Relative contribution of muscle strength, lean mass, and lower ...
In this study we determined the relative contribution of lean mass, muscle strength, and the four square step test, as an index of lower extremity motor ...
Effect of sit-to-stand-based training on muscle quality in ...
Keywords: Muscle power, Sarcopenia, Muscle quality index, Chair stand, Muscle architecture ... Three sets of five repetitions were timed, with a 1 ...
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